Senior Global Trial Managers (SGTMs) are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster. The SGTM is a member of the core project team responsible for clinical delivery of large, multi-regional studies to meet contractual requirements and in accordance with SOPs, policies and practices. SGTMs ensure clinical delivery to customers by leading clinical teams and partnering with other functional teams to ensure projects meet delivery requirements at all times.
Responsibilities
- Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).
- Accountable for meeting projects’ Clinical targets
- Contribute to the development of the project risk mitigation plan. Manage clinical risks through the project lifecycle.
- Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.
- Manage clinical aspects of Project. Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against Study work plan (SWP) and identify additional service opportunities or out of scope work to be manage on a Change in Scope (CIS) process.
- Work as the primary Point of contact for the customer project manager
- Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.
- Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements.
- Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.
- Conduct regular team meetings and communicate appropriately to achieve objectives.
- Support professional development by providing feedback to clinical team line managers on performance relative to project tasks to support professional development.
- Adopt corporate initiatives and changes and serve as a change advocate when necessary.
- May contribute to the development of the clinical delivery strategy for business proposals. Participate in bid defense preparations and meetings. Develop and present Clinical Operation plan in partnership with Business Development and Project Leadership.
- May mentor and coach new peers as they assimilate into this role.
- May attend site visits as applicable in support of project delivery.
Requirements
- Typically requires 3 - 5 years of prior relevant experience.
- Bachelor’s degree in health care or other scientific discipline required.
- Requires 7 years clinical research/monitoring experience or equivalent combination of education, training and experience.
- Requires consolidated knowledge and understanding of Project management practices and terminology.
- Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Requires broad protocol knowledge and therapeutic knowledge.
- Requires good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates.
- Requires understanding of project finances to oversee the clinical/monitoring budget and changes to scope.
This position is not eligible for UK VISA Sponsorship
Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered.
The potential base pay range for this role, when annualized, is 217.800,00 - 404.600,00 PLN zł. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
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